Reduce tremor stiffness and slowness
- Trial ID
- NCT06169852
- Official Title
- Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD
- Goal
- Reduce tremor stiffness and slowness
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Alabama at Birmingham
- Study Type
- INTERVENTIONAL
- Enrollment
- 36 participants
- Conditions
- Parkinson Disease
- Interventions
- Unilateral dual-target (STN/GPi) DBS
Plain-Language Summary
The goal is to better control disabling motor problems like wearing off, dyskinesias, and on/off fluctuations by improving how deep brain stimulation reaches two key targets, the subthalamic nucleus and the globus pallidus interna. During awake, unilateral surgery surgeons record stimulus-evoked directional field potentials, intraoperative electrical signals that help steer directional DBS leads so stimulation more precisely modulates motor circuits; DBS then delivers continuous high-frequency pulses to STN and/or GPi to reduce tremor, rigidity, and slowness and to smooth out levodopa-related fluctuations and dyskinesia. Adults 18 to 89 with advanced, levodopa-responsive idiopathic Parkinson's disease for at least 4 years who still have disabling motor fluctuations or dyskinesias despite medical therapy, and who meet basic cognitive and mood criteria and can tolerate awake surgery, are being enrolled.
Locations
- University of Alabama at Birmingham, Birmingham, Alabama, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Unilateral dual-target (STN/GPi) DBS. The goal is to better control disabling motor problems like wearing off, dyskinesias, and on/off fluctuations by improving how deep brain stimulation reaches two key targets, the subthalamic nucleus and the globus pallidus interna. During awake, unilateral surgery surgeons record stimulus-evoked directional field potentials, intraoperative electrical signals that help steer directional DBS leads so stimulation more precisely modulates motor circuits; DBS then delivers continuous high-frequency pulses to STN and/or GPi to reduce tremor, rigidity, and slowness and to smooth out levodopa-related fluctuations and dyskinesia. Adults 18 to 89 with advanced, levodopa-responsive idiopathic Parkinson's disease for at least 4 years who still have disabling motor fluctuations or dyskinesias despite medical therapy, and who meet basic cognitive and mood criteria and can tolerate awake surgery, are being enrolled.
- Who can participate?
- Participants must be between 18 Years and 89 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 4 years and 11 months.